FDA 483 - Northwest Eye Design, LLC - February 02, 2024

On February 2, 2024, the Food and Drug Administration (FDA) conducted an inspection of Northwest Eye Design, LLC, a manufacturer of prosthetic eyes located in Kirkland, WA. The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations concerning compliance with quality system requirements and labeling regulations.The first observation noted the company's failure to assess the impact on device quality when test/measurement equipment, specifically a Liquisteam machine, was found to be out of its accuracy and precision limits in 2018. This issue was highlighted as a recurring observation, indicating a persistent deficiency in evaluating the potential adverse effects of non-conforming equipment on product quality.The second observation identified that the labels for the firm's Class I medical devices, prosthetic eyes, did not bear a Unique Device Identifier (UDI) as mandated by 21 CFR 801 Subpart B and 21 CFR 830. This omission represents a failure to meet critical regulatory labeling requirements designed for improved device traceability and patient safety.Northwest Eye Design, LLC is responsible for addressing these observations by conducting thorough internal self-audits and implementing corrective actions. The firm indicated that the equipment evaluation issue was "promised to correct," while the UDI labeling observation was "under consideration." These actions are crucial for ensuring ongoing compliance with FDA regulations and maintaining the quality and safety of their manufactured medical devices.